A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems (CHARACTER SCS)

Abbott

Status

Terminated

Conditions

Chronic Pain

Treatments

Device: Treatment with the Axium SCS system

Device: Treatment with the Medtronic SCS System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02250469

12-SMI-2014

Details and patient eligibility

About

12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in patient experiences with two different types of Spinal Cord Stimulator devices which are routinely used to treat chronic pain.

Enrollment

5 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject is appropriate for SCS implantation according to standard criteria
Subject is >18 to <75 years old
Subject is able and willing to comply with the follow-up schedule and protocol
Subject has chronic (> 6 months) uni/bi-lateral neuropathic pain in the lower limb(s) (below the knee) with predominant foot pain
Minimum baseline pain rating of 50 mm on the VAS in the primary region of pain
Subject is able to provide written informed consent

Exclusion criteria

Subject has no other exclusion criteria for SCS implantation according to standard criteria
Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
Subject has participated in another clinical study within 30 days
Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy